Craniofacial Surgery and Adverse Outcomes: An Inquiry Into Medical Negligence.

OBJECTIVE: This study aimed to evaluate factors contributing to medical negligence relevant to craniofacial surgery. METHODS: Retrospective analysis of verdict and settlement reports on the Westlaw legal database for outcome, awards, physician defendants, and other specific factors raised in malpractice litigation. RESULTS: Of 42 verdicts and settlement reports included, 52.4% were resolved with either an out-of-court settlement or plaintiff verdict, with aggregate payments totaling $50.1M (in 2013 dollars). Median settlements and jury-awarded damages were $988,000 and $555,000, respectively. Payments in pediatric cases ($1.2M) were significantly higher. Plastic surgeons, oral surgeons, and otolaryngologists were the most commonly named defendants. The most common alleged factors included intraoperative negligence (69.0%), permanent deficits (54.8%), requiring additional surgery (52.4%), missed/delayed diagnosis of a complication (42.9%), disfigurement/scarring (28.6%), postoperative negligence (28.6%), and inadequate informed consent (20.6% of surgical cases). Failure to diagnose a fracture (19.0%) and cleft-reparative procedures (14.3%) were the most frequently litigated entities. CONCLUSION: Medical negligence related to craniofacial surgery involves plaintiffs in a wide age range as well as physician defendants in numerous specialties, and proceedings resolved with settlement and plaintiff verdict involve substantial payments. Cases with death, allegedly permanent injuries, and pediatric plaintiffs had significantly higher payments.

Meningitis and legal liability: an otolaryngology perspective.

PURPOSE: Meningitis is a potential complication in otolaryngologic procedures and conditions. Severe sequelae make understanding factors involved in relevant malpractice litigation critical. We analyze pertinent litigation for awards, outcomes, patient demographic factors, and other alleged causes of malpractice. METHODS: Pertinent jury verdict and settlement reports were examined using the Westlaw legal database (Thomson Reuters, New York, NY). RESULTS: Twenty-three cases (60.5%) involved non-iatrogenic injuries, including inadequate treatment or failure to diagnose sinusitis or otitis media, while 15 (39.5%) involved iatrogenic cases, mostly rhinologic procedures. 36.8% of cases were resolved for the defendant, 28.9% with juries awarding damages, and 34.2% with settlements. Although not statistically significant, mean damages awarded were higher than settlements ($2.1 vs. 1.5M, p=0.056), and cases involving pediatric patients were more likely to be resolved with payment than those with adult litigants (80.0% vs. 52.2%, p=0.08 respectively). Other frequent alleged factors included permanent deficits (63.2%), requiring additional surgery (41.1%), death (34.2%), cognitive deficits (21.2%), deafness (15.8%), and inadequate informed consent (33.0% of iatrogenic cases). CONCLUSIONS: Practitioners facing litigation related to meningitis may wish to consider these findings, notably for cases involving death or permanent functional deficits, as cases with out of court settlements tended to be resolved with lower payments. Cases involving misdiagnosis may be more likely to be resolved with payment compared with iatrogenic cases. By understanding the issues detailed in this analysis and including them in the informed consent process for patients undergoing rhinologic and otologic procedures, otolaryngologists may potentially improve patient safety and decrease liability.

Determining legal responsibility in otolaryngology: a review of 44 trials since 2008.

PURPOSE: Medicolegal factors contribute to increasing healthcare costs through the direct costs of malpractice litigation, malpractice insurance premiums, and defensive medicine. Malpractice litigation trends are constantly changing as a result of technological innovations and changes in laws. In this study, we examine the most recent legal decisions related to Otolaryngology and characterize the factors responsible for determining legal responsibility. METHODS: The Westlaw legal database (Thomson Reuters, New York, NY) was used to search for jury verdicts since 2008 in Otolaryngology malpractice cases. The 44 cases included in this analysis were studied to determine the procedures most commonly litigated and progressing to trial, as well as the year, location, alleged cause of malpractice, specialty of co-defendants, and case outcomes. RESULTS: Out of the 44 cases included in this analysis, physicians were not found liable in 36 (81.8%) cases. Rhinologic procedures comprised 38.6% of cases litigated, and rulings were in physicians' favor in 66.7% of endoscopic sinus surgery (ESS) cases and all non-ESS rhinologic cases. A perceived lack of informed consent was noted in 34.1% of cases. The 8 jury awards averaged $940,000 (range, $148,000-$3,600,000). CONCLUSION: Otolaryngologists were not found liable in the majority of cases reviewed. Rhinologic surgeries were the most common procedures resulting in litigation. Adenotonsillectomies, thyroidectomies, and airway management are also well-represented. Perceived deficits in informed consent and misdiagnosis were noted in a considerable proportion of otolaryngologic malpractice cases resulting in jury decisions.

[Comprehensive review on danger points, complications and medico-legal aspects in endoscopic sinus surgery]. / Fehler und Gefahren: Eingriffe an den Nasennebenhöhlen und der Frontobasis unter Berücksichtigung mediko-legaler Aspekte.

Endoscopic endonasal sinus surgery represents the overall accepted type of surgical treatment for chronic rhinosinusitis. Notwithstanding raised and still evolving quality standards, surgeons performing routine endoscopic interventions are faced with minor complications in 5% and major complications in 0.5-1%.A comprehensive review on all minor and major complications of endoscopic surgery of the paranasal sinuses and also on the anterior skull base is presented listing the actual scientific literature. The pathogenesis, signs and symptoms of each complication are reviewed and therapeutic regimens are discussed in detail relating to actual publication references. Potential medico-legal aspects are explicated and recent algorithms of avoidance are mentioned taking into account options in surgical training and education.

Writing otorhinolaryngology head & neck surgery operative reports.

Only about ten articles devoted to operative reports have been published in the medical literature, but this document is essential, both medically and legally, to ensure optimal management of operated patients. In this technical note, based on published studies on this subject, the authors describe the key features of operating reports after otorhinolaryngology head & neck surgery and emphasize the need to write this document during the minutes after the end of the operation, the importance of standardization and its teaching role during surgical training.

Medical malpractice and transoral robotic surgery: Evaluation and some preemptive thoughts.

Medical malpractice is costly and disruptive, and it is important to prevent. We conducted a study with the objective to look at medical malpractice in robotic surgery overall, to evaluate reasons for litigation, and to comment on possible strategies to avoid litigation with transoral robotic surgery. We used the Westlaw computerized database to identify all state and federal verdict summaries in medical malpractice cases. We found 17 cases alleging malpractice that involved the use of robotic surgery. In all, the plaintiffs in 6 cases (35%) contended that an open rather than a robotic approach should have been used, 5 (29%) alleged negligent credentialing, 4 (24%) alleged training deficiencies, 2 (12%) alleged manufacturing problems, and 1 (6%) charged that robotic surgery should have been performed instead of open surgery (1 case involved two of these allegations). In 11 cases (65%), plaintiffs charged that robotic surgery contributed to an undesirable outcome, and in 6 cases (35%) they raised concerns about informed consent. In all, only 5 of the 17 lawsuits (29%) resulted in plaintiff verdicts or settlements; damages ranged from $95,000 to $7.5 million. We believe the courts should not play a major role in establishing safety guidelines for the introduction of new technology such as robotic surgery. Instead, training and credentialing guidelines should be established by appropriate national associations and societies to assist hospitals in doing so.

Rhinology and medical malpractice: An update of the medicolegal landscape of the last ten years.

OBJECTIVES/HYPOTHESIS: Malpractice claims pertaining to rhinological procedures are a potentially important source of information that could be used to minimize the risk of future litigation and improve patient care. STUDY DESIGN: A retrospective review of a publicly available database containing jury verdicts and settlements. METHODS: The LexisNexis Jury Verdicts and Settlements database was reviewed for all lawsuits and out-of-court adjudications related to the practice of rhinology. Data including patient demographics, type of surgery performed, plaintiff allegation, nature of injury, outcomes, and indemnities were collected and analyzed. RESULTS: Of 85 cases meeting inclusion criteria, 42 were decided by a jury and 43 were adjudicated out of court. Endoscopic sinus surgery was the most commonly litigated surgery. The plaintiff was favored when the eye was injured (P = 0.0196), but the defendant was favored when neuropsychological injuries (P = 0.0137) or recurrent/worsened symptoms (P = 0.0050) were cited. No difference was found when death or skull base injuries occurred. When lack of informed consent was an allegation, the defendant was favored (P = 0.0001). A payout was made in two-thirds of cases overall, but the defendant was favored in two-thirds of cases decided by a jury. Payments were significant for both out-of-court settlements ($1.3 million) and jury verdicts ($2 million). CONCLUSIONS: Endoscopic sinus surgery remains the most commonly litigated rhinology procedure and has the potential to result in large payouts. Meticulous dissection, recognition of complications, and documentation of informed consent remain paramount for providing optimal patient care.

Laryngology litigation in the United States: Thirty years in review.

OBJECTIVES/HYPOTHESIS: Malpractice claims pertaining to laryngology procedures are a potentially important source of information that could be used to minimize the risk of future litigation and improve patient care. STUDY DESIGN: A retrospective review of two publicly available databases containing jury verdicts and settlements. METHODS: The LexisNexis Jury Verdicts and Settlements and WestlawNext legal databases were reviewed for all lawsuits and out-of-court adjudications related to the practice of laryngology. Data including patient demographics, type of surgery performed, plaintiff allegation, nature of injury, outcomes, and indemnities were collected and analyzed. RESULTS: Of 87 cases meeting inclusion criteria, 56 were decided by a jury and 31 were adjudicated out of court. Vocal cord surgery was the most commonly litigated surgery. The two most commonly cited legal allegations were physical injury and negligence. No statistical difference for legal outcome was found when death or vocal cord injuries occurred. Complications in procedures that utilized a laser predicted an unfavorable outcome (P = 0.013). A payout was made in over one-half of cases, but defendants were favored in over two-thirds of cases decided by a jury. The average indemnities were significant for both jury verdicts ($4.6 million) and out-of-court settlements ($0.9 million). CONCLUSION: An awareness of laryngology malpractice litigation has the potential to provide better patient care and help laryngologists avoid potential risks for litigation. The factors determining legal responsibility in laryngology cases underscore the importance of close communication with anesthesiologists and careful evaluation of hoarseness in all patients regardless of risk factors. LEVEL OF EVIDENCE: N/A. Laryngoscope, 126:2301-2304, 2016.

Informed consent in sinus surgery: link between demographics and patient desires.

OBJECTIVE: To evaluate and understand differences in expectations according to patient demographics during the informed consent process for functional endoscopic sinus surgery (FESS). STUDY DESIGN: Multi-institutional, cross-sectional survey design. METHODS: Anonymous surveys were administered to patients in two tertiary academic centers with a chief complaints relating to "allergy and sinus" problems. Patients completed and eight-item questionnaire that assessed demographics and the nature and level of risks that patients wished to be informed of before FESS. Univariate and multivariate analyses were performed to assess for differences in patient desires related to FESS risks according to demographics. RESULTS: Three hundred eighty-nine completed surveys were analyzed. Younger patients (P = .049), white patients (P = .0026), and more educated patients (P = .0033) wished to know about complications at the lowest risks levels (lowest incidence), regardless of severity. With regards to specific complications, black patients and patients with less formal education were less interested in being informed about the potential risks of orbital complications, cerebrospinal fluid leak, or possible need for revision surgery. Multivariate analysis confirmed that race, education, age were independently significant factors in determining response. CONCLUSION: Demographic-related differences exist in patient's desires and expectations in the informed consent process for a sinus procedure. Physicians should be aware of these differences when counseling patients about sinus surgery. More research is needed to elucidate the factors that underlie the observed differences.

Stereotactic computer assisted navigation: state of the art for sinus surgery, not standard of care.

There are circumstances in which image guidance is clearly useful to facilitate a more complete operation. By confirming the identity of known anatomic structures, a knowledgeable surgeon's understanding of the disease process can improve and only the necessary structures removed. CT guidance is a clear aid to understanding altered anatomy when combined with a thorough analysis of the preoperative CT scan and office nasal endoscopy. It is the combination of this preoperative planning with image guidance that allows a skilled surgeon to operate with confidence. This discussion intentionally did not refer to image guidance as the standard of care, because although this technology is clearly useful, valuable, and helpful in confirming anatomy and performing many procedures, it is not always necessary in achieving a complete operation. Therefore, it should not be considered the standard of care.

Medical malpractice and facial nerve paralysis.

BACKGROUND: Iatrogenic facial nerve paralysis is a devastating surgical complication that occasionally results in litigation. OBJECTIVE: To analyze litigation trends to better understand the causes and outcomes of suits involving facial nerve paralysis to prevent future litigation and improve physician education. DESIGN: Retrospective review. SETTING: All US civil trials. PARTICIPANTS: All state and federal civil trials alleging malpractice and facial nerve paralysis were reviewed. METHODS: Jury verdict reviews from January 1, 1985, to December 31, 2000, were obtained from a computerized legal database and analyzed. Reviews compile data on defendants, plaintiffs, allegations of wrong doing, and expert witness specialties, and provide case summaries. Fifty-three cases from 19 of the 50 states were obtained. Data were entered into a spreadsheet for analysis. MAIN OUTCOME MEASURES: Verdicts and indemnity payments. RESULTS: Suits reviewed were as follows: cosmetic, 12 (23%); otologic, 13 (25%); nonneoplastic disease of the parotid or other benign conditions of the head and neck, 15 (28%); benign neoplasms of the parotid, 9 (17%); malignant neoplasms of the parotid, 1 (2%); and temporomandibular joint operations, 3 (6%) (percentages do not total 100 because of rounding). Allegations of negligence were frequently multiple and included lack of informed consent (16 [30%] of 53), failure to diagnose (10 [19%] of 53), and surgical misadventures (47 [89%] of 53). Excluding failure to obtain consent or to diagnose, 28 suits still alleged negligence based solely on a surgical misadventure. Of these suits, 12 (63%) resulted in plaintiff awards. CONCLUSIONS: Surgeons must emphasize and document the likelihood and consequences of this devastating complication to all patients undergoing surgery in this area. Risk management goals include a thorough and timely examination and careful and thoughtful surgical approaches. However, patient rapport and bedside manner may be the only protection the surgeon has from litigation arising from this complication.

Protecting the most vulnerable: litigation from pediatric otolaryngologic procedures and conditions.

OBJECTIVES/HYPOTHESIS: To identify allegations raised in litigation stemming from pediatric otolaryngologic procedures and conditions. STUDY DESIGN: Retrospective analysis of a legal database. METHODS: The authors reviewed jury verdict and settlement reports on the WestlawNext database from 1994 to 2013 for cases involving pediatric plaintiffs and alleged negligence in otolaryngologic procedures and conditions. RESULTS: Of the 78 cases included, 52.6% were resolved with a payment; aggregate payments exceeded $69 million, and median jury-awarded damages and settlements were $874,190 and $250,000, respectively. Adenotonsillectomy was the most commonly litigated procedure. Otolaryngologists were defendants in 42 (53.8%) cases, with pediatricians and anesthesiologists the next most commonly named defendants. Forty-six (59.0%) cases involved alleged negligence in operative management, whereas other factors included permanent injury (44.9%), misdiagnosis/failure to diagnose in a timely manner (41.0%), death (35.9%), and requiring additional surgery. Airway-related complications and allegedly permanent injuries significantly increased the size of payments. Awards were highest in cases with plaintiffs at 1 to 5-years of age and lowest among children older than 10 years of age. CONCLUSIONS: Unique considerations specific to pediatric patients are involved in malpractice litigation, and damages awarded were considerable. By including the specific factors listed in this analysis in a comprehensive informed consent process, and recognizing concerns specific to this patient population, practitioners in multiple specialties may potentially reduce liability. Clear communication with parents is a critical component of this process.

Systematic analysis of ear-nose-throat malpractice complaints may be beneficial for patient safety.

INTRODUCTION: The analysis of malpractice complaints can provide valuable information on patient safety. This study offers a detailed examination of the backgrounds concerning reasons and outcomes of ear, nose and throat (ENT) malpractice complaints handled by the National Board of Patients' Complaints (NBPC), 1998-2008. MATERIAL AND METHODS: All NBPC decisions related to the ENT specialty from 1998-2008 in Denmark were analysed. RESULTS: Deficient medical recording was criticized even though the complainant did not mention this in the complaint. The juridical theme of medical error was the most complained about, but the least criticized compared with six other juridical themes. In contrast, retained packaging, wrong-site surgery, laser burns and peeling injuries were medical errors with high rates of criticism. Complaints concerning accidental surgical complications did not lead to criticism. Tonsillectomy was the most frequently alleged ENT operation in our study data. CONCLUSION: Thorough preoperative information about potential surgical complications undersigned by the patient and the newly introduced safe surgery procedures are likely to reduce both faults and complaints. Malpractice complaints have not hitherto been used as a learning instrument. We propose a systematic registration of these incidents to enable more learning in the future. The new act on the handling of malpractice complaints may make it easier to avoid malpractice and to learn from malpractice complaints and may thus improve patient safety in Denmark. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Medicolegal issues in endoscopic sinus surgery.

Endoscopic sinus surgery is one of the most litigated areas in otolaryngology. Physicians typically receive little education regarding medicolegal issues during training and may find themselves in an unfamiliar territory during litigation. This article reviews the scope of the problem and provides strategies to improve patient care and mitigate medicolegal risk in endoscopic sinus surgery.

Malpractice claims in nasal and sinus surgery: a review of 15 cases.

Otolaryngologists may encounter claims of medical malpractice during the course of their careers. A sample of 15 cases involving patient claims of medical malpractice relating to care delivered for problems of the nose and paranasal sinus is presented. A short summary of each case is provided, which may be useful to practicing otolaryngologists.